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CTRI Number  CTRI/2025/02/081339 [Registered on: 25/02/2025] Trial Registered Prospectively
Last Modified On: 24/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Quality of recovery in patients undergoing kidney stone extraction surgery with Regional block and General Anaesthesia. 
Scientific Title of Study   Quality Of Recovery In Patients Undergoing Percutaneous Nephrolithotomy Under Opioid Free General Anaesthesia With Erector Spinae Block :A Prospective Observational Study  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kotla Likith 
Designation  MD Anaesthesiology  
Affiliation  Lokamanya Tilak Municipal Medical College and Hospital  
Address  Department of Anaesthesiology, Lokamanya tilak municipal medical College and Hospital ,Sion, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400022
India 
Phone  7093434392  
Fax    
Email  likithkotla15@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Devangi Parikh 
Designation  Associate professor, Department of anaesthesiology 
Affiliation  Lokamanya Tilak Municipal Medical College and Hospital  
Address  Department of anaesthesiology, Lokamanya tilak municipal medical College and hospital,Sion, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400022
India 
Phone  9820471638  
Fax    
Email  sdevangi10@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Kotla Likith 
Designation  MD Anaesthesiology  
Affiliation  Lokamanya Tilak Municipal Medical College and Hospital  
Address  Department of anaesthesiology, Lokamanya tilak municipal medical College and Hospital,Sion, Mumbai, Maharashtra

Mumbai
MAHARASHTRA
400022
India 
Phone  7093434392  
Fax    
Email  likithkotla15@gmail.com  
 
Source of Monetary or Material Support  
Lokamanya Tilak Municipal Medical College and Hospital,Sion, Mumbai, Maharashtra,400022 
 
Primary Sponsor  
Name  Dr Kotla Likith  
Address  Room no-405,New RMO hostel, Sion, Mumbai, Maharashtra,400022 
Type of Sponsor  Other [Self sponsored] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kotla Likith   Lokamanya Tilak Municipal Medical College and Hospital   Department of anaesthesiology,Lokamanya tilak municipal medical College and Hospital hospital,sion, Mumbai, Maharashtra,400022
Mumbai
MAHARASHTRA 
7093434392

likithkotla15@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research LTMMC&GH  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N202||Calculus of kidney with calculus of ureter,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Erector Spinae Block  Under USG guidance ESP block given with 15 ml of 2% lignocaine adrenaline & 15 ml of 0.5% ropivacaine plus dexmedetomidine 0.5 mcg/kg at T8 level. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  All patients presenting for percutaneous nephrolithotomy surgeries in the age group of 18-60 yrs in which general anaesthesia with Opioid free anaesthesia plus regional block was given  
 
ExclusionCriteria 
Details  patients not giving consent, sensitivity to local anaesthetics, history of drug abuse,use of chronic pain medications  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To observe and calculate the post operative quality of recovery score in patients undergoing pcnl surgery with opioid free anaesthesia plus regional block using QOR-15 questionnaire  Post 24 hrs from surgery  
 
Secondary Outcome  
Outcome  TimePoints 
Post operative pain score
Post operative nausea and vomiting
Post operative urinary catheter discomfort
Total rescue analgesia required in post operative period
Adverse effects if any 
1,6,12,24 hrs after surgery  
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION AND BACKGROUND OF THE PROPOSED PROJECT

 Percutaneous nephrolithotomy (PCNL) is a very common surgical technique used for the treatment of renal stones. During PCNL,
postoperative pain is a complex condition that needs a multimodal approach and good pain management.It can decrease hospital stay,
rate of complications, and decrease overall health cost. Conventional postoperative pain management with opioids compromise early
recovery and discharge due to their side effects. Thus, the multimodal postoperative pain management approach helps in reducing
opioid-related side effects.[1]
 Opioid analgesics are a cornerstone for providing perioperative analgesia. They suppress the neuro-endocrine response during
surgery, and this helps to maintain stable intraoperative hemodynamics. However, perioperative use of opioid analgesics has deleterious
side effects such as respiratory depression, nausea, vomiting, urinary retention,gastrointestinal dysfunction, delirium, pruritus, and last
but not least opioid addiction.
[2]
In a recent study, 12% of surgeries had some kind of opioid-related adverse events.[3]These adverse
effects can lead not only to prolonged hospital admissions, but to unplanned hospital admission, dependence, addiction, hyper-algesia,
and the development of chronic pain as well . Patients with opioid-related adverse events can have nearly twice the treatment costs,
double the length of stay, and significantly higher readmissions to the hospital . [4]

Most of the patients undergoing PCNL have compromised renal function. Nonsteroidal anti-inflammatory drugs (NSAIDs), which
provide excellent opioid-free analgesia is relatively contraindicated in such conditions, hence any technique or drug that can avoid side
effects of opioids and complications of NSAIDs is desirable.[5][6]
Opioid free anesthesia (OFA) is a multimodal procedure combining non-opioid drugs with or without regional anesthesia techniques
that allow a better quality of anesthesia and patient satisfaction.[7]The simultaneous use of non-opioid analgesic drugs
(eg,Dexmedetomidine, magnesium sulfate, xylocaine, and acetaminophen) can have a synergistic effect that improves postoperative
analgesia and prevents opioid-related adverse effects (nausea, vomiting, ileus, sedation, and respiratory Depression) while facilitating
early movement. OFA can fulfil the implementation of enhanced recovery after surgery (ERAS) protocols designed for rapid recovery
after major operations, supporting organ function, and decreasing stress response caused by surgical trauma.[8][9][10]

Erector Spinae Plane Block (ESPB) was first described in 2016 by Forero et al, as a regional anesthetic technique. Local anesthetic
injected into this erector spinae fascial plane spreads in a craniocaudal fashion over several levels and to the paravertebral space, thereby
targeting the dorsal and ventral rami of the spinal nerve. Thus, it can provide both somatic and visceral sensory blockade, making it an
ideal regional anesthetic technique for abdominal and thoracic surgeries.
[11][12] 


Quality of recovery (QOR) after anesthesia is an important measure of the early postoperative health status of patients. It incorporates
five dimensions of health: patient support, comfort, emotions, physical independence, and pain. Post operative recovery is an important
parameter in determining discharge in this group of patients. QOR 15 provides a valid, reliable, extensive and efficient evaluation of
patients quality of recovery after anaesthesia and surgery[15]

Hence we are undertaking this observational study to assess the quality of recovery in patients undergoing PCNL surgery with OFA
plus regional block.


 
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